Jazz Receives FDA Approval for Xyrem's (sodium oxybate) sNDA to Treat Cataplexy or Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy
Shots:
- The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs.
- P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks- change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in the Lancet Child & Adolescent Health 2018
- to Micromedex DRUGDEX monograph- Xyrem (CIIA) is recommended for cataplexy in narcolepsy in the pediatric patient and also a novel FDA approved PO (CIII) drug for pediatric patients (7 yrs) & adults indicated for cataplexy and excessive daytime sleepiness in narcolepsy
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
